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Northfield Receives Complete Response Letter for PolyHeme(R) BLA
8:01p ET April 30, 2009 (Business Wire)
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it has received a complete response letter from the U.S. Food and Drug Administration pertaining to the Company's Biologic License Application for its investigational product, PolyHeme, indicated for the treatment of life-threatening hemoglobin levels when blood transfusion is indicated and red blood cells may not be available.

The letter states that FDA has completed its review of the Company's BLA and finds "that the information and data submitted are inadequate for final approval action." Specifically, FDA stated that the Company's pivotal study "... did not meet the pre-specified primary efficacy endpoint," and that "based on the totality of the data in the application, FDA has determined that the data submitted do not support the proposed indication."

FDA also noted that "the safety data of all controlled studies reveal that the administration of PolyHeme places the patients at a higher risk of significant adverse events," and stated that "therefore, in the absence of clinical benefit, the risk:benefit assessment of the product in trauma is unfavorable."

Northfield is evaluating FDA's response and is considering the options for the Company going forward.

About Northfield Laboratories

Northfield Laboratories is developing a hemoglobin-based oxygen-carrying red blood cell substitute, PolyHeme. PolyHeme is a solution of chemically modified human hemoglobin that requires no cross-matching and is therefore compatible with all blood types. It has an extended shelf life in excess of 12 months. For further information, visit http://www.northfieldlabs.com.